CARDICARE MODEL MT-301F & MT-301C

K032714 · Lumiscope Co., Inc. · FLL · Oct 22, 2003 · General Hospital

Device Facts

• Record ID: K032714
• Device Name: CARDICARE MODEL MT-301F & MT-301C
• Applicant: Lumiscope Co., Inc.
• Product Code: FLL · General Hospital
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The Cardicare MT-301F & MT-301C Thermometers have the same intended use as the predicate device. It is indicated for use in the measurement of oral, axillary and rectal temperature. The MT-301F & MT 301C Thermometers are intended for home use by the patient.

Device Story

Digital electronic thermometer; consists of sensor tip, connecting probe, and display unit. Operates via electrical transducer design; probe houses transducer and circuitry; display unit contains 1.55V DC button battery, LCD, and push-button switch for temperature control and alert beeper. Intended for home use by patients for oral, axillary, or rectal temperature measurement. Provides digital temperature readout to assist in monitoring body temperature.

Clinical Evidence

Bench testing only. Testing performed by QC Lab by Sejoy Electronics, China, confirmed accuracy, precision, and repeatability measurements as specified in labeling.

Technological Characteristics

Digital electronic thermometer; electrical transducer design; 1.55V DC button battery power source; LCD display; push-button switch; probe with transducer and plastic housing.

Indications for Use

Indicated for oral, axillary, and rectal body temperature measurement in patients for home use.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Jasun, Model DT-01F, Hangzhou Hua'an Medical & Health Instruments Company

Submission Summary (Full Text)

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## OCT 2 2 2003

K032714

## 510(K) SUMMARY- CARDICARE MODEL MT-301F & MT-301C THERMOMETER

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92

| Priority Name:<br>Common/ Usual Name:<br>Classification Name:<br>Legally Marketed Device: | Cardicare Model MT-301F & MT-301C<br>Digital Electronic Thermometer<br>Clinical Electronic Thermometer (per 21 CFR 880.2910)<br>Jasun, Model DT-01F, Hangzhou Hua'an Medical & Health<br>Instruments Company. |
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| Device Description: | The Cardicare Model MT-301F & MT-301C Thermometers are<br>thermometers of standard electrical transducer design, consisting<br>of a sensor tip, connecting probe and display unit. The probe<br>consists of a transducer and supporting plastic case, which houses<br>the connection between the sensor and the circuitry. The display<br>unit houses a 1.55V DC button battery, LCD and push button<br>switch for controlling temperature and alert beeper. |
| Intended Use: | The Cardicare MT-301F & MT-301C Thermometers have the<br>same intended use as the predicate device. It is indicated for use in<br>the measurement of oral, axillary and rectal temperature. The MT-<br>301F & MT 301C Thermometers are intended for home use by the<br>patient. |
| Techonoligical<br>Characteristic: | The Cardicare MT-301F & MT301-C Thermometers have the<br>same technological features as the predicate device: The mode of<br>operation, physical specifications, operational and biological<br>specifications are identical. |
| Performance Data: | QC Lab by Sejoy Electronics testing, China, performed on the<br>Cardicare MT-301F & MT-301C Thermometers confirmed<br>accuracy, precision and repeatability measurements specified in<br>labeling. |
| Substantial Equivalence: | The information provided demonstrates that the Cardicare MT-<br>301F & MT-301C Thermometers are substantially equivalent to<br>the predicate device since the devices have the same intended use, |

Viktoria

principles of operation and technological characteristics.

8/28/03

Contact Person:

Mario D. Manzano

Date Prepared

E-2

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 2 2 2003

Ms. Mario Manzano Director, Quality Assurance Lumiscope Company, Incorporated 122 Tices Lane East Brunswick, New Jersey 08816

Re: K032714

Trade/Device Name: Digital Fever Thermometer, Oral, Rectal and Axillary Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 13, 2003 Received: October 16, 2003

Dear Mr. Manzano:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Manzano

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runner

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K032714

Device Name: Digital Fever Thermometer, Oral, Rectal and Axillary

Indication For Use:

The Cardicare Model MT-301C and Model MT-301F digital thermometers are intended for use in the measurement of oral, axillary and rectal body temperature.

.

:

Patricia Cucente

(Division Sign-Off Division of Anesthesiology. General Hospital Infection Control, Dental

510(k) Number: K032714

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Concurrence of CDRH, Office of Device Evaluation (ODE)